Monoclonal Antibodies

IOV-4001 for Non-Small Cell Lung Cancer

Moffitt Cancer Center, Tampa, FL
Targeting 4 different conditionsIOV-4001Phase 1 & 2RecruitingResearch Sponsored by Iovance Biotherapeutics, Inc.

Study Summary

This trial will test a new cancer treatment called IOV-4001 on people with melanoma or NSCLC that has spread and can't be removed by surgery. They will be measuring how effective and safe it is.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Melanoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have at least one tumor that can be surgically removed.
You have melanoma or non-small cell lung cancer and have received previous therapies. If you have melanoma, you must have progressed within 12 weeks of receiving a specific type of medication. If you have non-small cell lung cancer, you must have received no more than three prior treatments and either progressed within 12 weeks of receiving a specific medication or during/after other treatments.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year or depending on when the recommended phase 2 dose is determined
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year or depending on when the recommended phase 2 dose is determined for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2: Objective Response Rate (ORR)
Phase I: Safety of IOV-4001
Secondary outcome measures
CR Rate
Disease Control Rate (DCR)
Duration of Response (DOR)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Participants with Stage III or IV non-small-cell lung cancer
Group II: Cohort 1Experimental Treatment1 Intervention
Participants with unresectable or metastatic melanoma

Find a site

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Lead Sponsor
19 Previous Clinical Trials
1,617 Total Patients Enrolled
Iovance Biotherapeutics Study TeamStudy Director
Iovance Biotherapeutics
2 Previous Clinical Trials
765 Total Patients Enrolled

Media Library

IOV-4001 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05361174 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Cohort 1, Cohort 2
Non-Small Cell Lung Cancer Clinical Trial 2023: IOV-4001 Highlights & Side Effects. Trial Name: NCT05361174 — Phase 1 & 2
IOV-4001 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361174 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are involved in this clinical experiment?

"The sponsor of this trial, Iovance Biotherapeutics Inc., is seeking to enrol a contingent of 53 patients that meet the study's criteria. These individuals will be recruited from locations such as Memorial Sloan Kettering Cancer Center in New York and University of Louisville in Kentucky."

Answered by AI

Are there still opportunities for enrolment in this clinical trial?

"Affirmative. records support that this clinical trial, which was launched on July 20th 2022, is actively recruiting participants. 53 individuals are needed from 3 locations to complete the study."

Answered by AI

What aims is this research endeavor attempting to achieve?

"The primary objective of this study, which will be tracked over a period up to 60 months, is to assess the safety profile of IOV-4001. Secondary endpoints include Disease Control Rate (DCR), Feasibility of IOV-4001 and Overall Survival (OS). Respectively, they measure response rate based on RECIST v1.1 criteria by an investigator, successful manufacturing with no delays or failures, as well as total time from infusion until death due any cause."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
University of Louisville
What portion of applicants met pre-screening criteria?
Met criteria
~31 spots leftby Jun 2025